BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD¿ SLIP-TIP BARREL WITH SCALE & SILICONE, BULK, NON-STERILE

    MDR report key: 6845537 · Received September 6, 2017

    Report

    Report Number
    1213809-2017-00097
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    December 11, 2016
    Report Date
    October 11, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER HISTORY REVIEW/DHR REVIEW COMPLAINT TRENDING REVIEW OF THE LOT FOR THESE ISSUES REVEALS THIS IS THE FIRST COMPLAINT. BASED ON DHR REVIEW, THERE WERE NO NON-CONFORMANCE RELATING TO THIS DEFECT. DHR/QN REVIEW FOR BATCH 7002571 (P/N 304050). NO QUALITY NOTIFICATIONS AND NO ISSUES RELATING TO THE COMPLAINT DEFECTS. BASED ON NO SAMPLES, THE INVESTIGATION CONCLUDED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BATCH #7002571 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO PHYSICAL SAMPLES AND NO PHOTOS WERE PROVIDED FOR EVALUATION. THEREFORE, SAMPLE EVALUATION COULD NOT BE PERFORMED, THE REPORTED DEFECTS COULD NOT BE CONFIRMED AND ROOT CAUSE IS UNDETERMINED. BASED ON THE INVESTIGATION PERFORMED TO DATE, THE DEFECT COULD NOT BE CONFIRMED AND ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKINGS WERE INACCURATE ON A BARREL 1CC S/T WITH SIL NO BD LOGO/TB BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625008 1 ML BD¿ SLIP-TIP BARREL WITH SCALE & SILICONE, BULK, NON-STERILE CONVENTIONAL SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7002571

    Patients

    Seq Age Sex Outcome Treatment
    1 Other